MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-01-29 for SMARTMONITOR 2 4003 manufactured by Philips Respironics - Chmv.
[3990695]
(b)(4) received a report from a (b)(6) supplier stating that an infant apnea monitor failed to alarm during a pt event. The date of the alleged event was on (b)(6) 2013. The (b)(6) stated that the caregiver reported that the pt expired and the monitor did not alarm. The (b)(6) has been contacted and stated that the device in question has been quarantined at their facility and that there were no plans to forward it to (b)(4) for evaluation. No additional information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
[11682349]
(b)(4). The device has not been returned to the manufacturer for evaluation. The device in question would need to be evaluated by (b)(4) to determine its condition. The smartmonitor 2 device is designed to monitor respiration, and heart rate. Upon detection of abnormal events, smartmonitor 2 alerts the caregiver via both visual and audible alarms and records the information for subsequent clinical review. The smartmonitor 2 acquires the electrical activity of the heart via a two or three-lead electrode configuration. The same set of electrodes is used to measure transthoracic impedance and to subsequently develop a respiration signal. Detection of heart beats and respiration breaths is accomplished via software-based algorithms, which analyze the ecg and respiration signals. When beats or breaths are detected, smartmonitor 2 provides feedback by blinking the heart and respiration led's and calculates apnea intervals, average heart rates and average breath rates for the purpose of identifying ecg and respiration rates that violate preset threshold values, in addition to the alarms, when abnormal ecg and respiration rates are detected, both tabular data and associated waveforms are logged in non-volatile memory for subsequent review. The user of this equipment is responsible for reading, understanding, and following the warning and caution statements throughout this manual. Quality assurance has concluded that at this time the customer complaint allegation could not be substantiated. No determination has been made as to the relationship, if any, of the device to the reported incident by (b)(4). Once the device in question is returned for investigation, a follow-up report will be filed detailing the findings.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007056120-2014-00002 |
| MDR Report Key | 3634540 |
| Report Source | 05 |
| Date Received | 2014-01-29 |
| Date of Report | 2013-12-30 |
| Date of Event | 2013-12-30 |
| Date Mfgr Received | 2013-12-30 |
| Device Manufacturer Date | 2004-08-01 |
| Date Added to Maude | 2014-02-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHRIS FERGUSON |
| Manufacturer Street | 191 WYNGATE DR |
| Manufacturer City | MONROEVILLE PA 15146 |
| Manufacturer Country | US |
| Manufacturer Postal | 15146 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NO |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMARTMONITOR 2 |
| Product Code | FLS |
| Date Received | 2014-01-29 |
| Model Number | 4003 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS RESPIRONICS - CHMV |
| Manufacturer Address | 191 WYNGATE DRIVE MONROEVILLE PA 15146 US 15146 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2014-01-29 |